The use of drug product is widespread and touches all aspects of our daily lives without our knowing it. From aspirin to cardiac medicine and from hormones in animal feed to over-the-counter dietary supplements, these products are used every day. What they all have in common are specific government regulations known as Good Manufacturing Practices established to ensure that the drug product is safe, pure, and effective. They intend to ensure that all aspects of manufacturing use proper science to ensure the integrity and validity of all information and data used. These regulations can all be found under their respective sections of the Code of Federal Regulations.

Routine medical laboratories involved in patient care are covered by well-defined international quality standards (ISO 15189) and national laws (42 CFR 493). In pharmaceutical research and development, only the nonclinical (not involving humans) laboratory safety studies are governed by the Good Laboratory Practices (GLP) regulations (21 CFR 58). No other well-defined quality standards exist for other so-called non-GLP laboratory research. This leads to the absurd situation that in a research laboratory, for example, a blood sample from a rabbit is theoretically subject to a stricter quality standard than a human sample. The FDA expects that “sound quality principles” are applied to the processing of human samples, but these principles are nowhere defined.

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